The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Sl Outer Catheter.
| Device ID | K053277 |
| 510k Number | K053277 |
| Device Name: | CPS DIRECT SL OUTER CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Contact | Deanna Hughes |
| Correspondent | Deanna Hughes ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-23 |
| Decision Date | 2006-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734508858 | K053277 | 000 |
| 05414734504287 | K053277 | 000 |